The present invention generally relates to a method and apparatus used for compensating pressure differences between an inlet and outlet of a pump, and more specifically, to a method and apparatus for compensating pressure differences across the inlet and the outlet of a cassette type infusion pump used to deliver medicinal fluids intravascularly.
Various types of pumps are used by medical personnel to infuse drugs into a patient""s body. Of these, cassette infusion pumps are often preferred because they provide a more accurately controlled rate and volume of drug infusion than other types of infusion pumps. A cassette pump employs a disposable plastic cassette coupled in a fluid line extending between a drug reservoir and the patient""s body.
In one prior art design of a cassette infusion pump, the cassette comprises a plastic shell or housing having a front section joined to a back section. A thin elastomeric sheet or membrane is encapsulated between the two sections. Fluid flows from one of two selectable inlet ports into a pumping chamber defined by a concave depression in one of the sections through passages formed in the housing. The cassette is inserted into an appropriate receptacle of a pump chassis that includes a microprocessor controller and a motor actuated driver. A plunger actuated by the motor in the pump driver displaces the elastomeric membrane to force fluid from the pumping chamber toward an outlet port under pressure. The pump chassis thus provides the driving force that pumps fluid through the cassette. The microprocessor control is programmable to deliver a selected volume of fluid to the patient at a selected rate of flow. In addition, the pump chassis may include one or more pressure sensors and air bubble sensors used to monitor the drug infusion process to protect against potential problems that may arise during the drug delivery.
Both single and multi-channel cassette pumps are available. A multi-channel cassette pump allows more than one type of medicinal fluid to be selectively delivered to a patient using a single pump cassette. Such pumps are frequently used in association with intravenous (IV) drug delivery therapies.
When the pump inlet and outlet pressure conditions are approximately equal, cassette type infusion pumps are quite accurate. However, when the pressures at the pump inlet and outlet vary substantially, the delivery accuracy of cassette pumps degrade. If the delivery rate is relatively low, as is often the case in pediatric applications, and if the differential pressure exceeds 3 psi, accuracy is significantly impaired, and retrograde flow can occur. In retrograde flow, fluid moves from the patient""s vascular system towards the pump, which can result in blood from a patient being drawn out of the patient""s body and into the IV line. Even if such retrograde flow occurs only briefly, and the accuracy of the delivery rate is not severely impaired, the visual impact of even a small amount of blood in an IV line can be extremely disturbing to care providers, patients, and visitors. Retrograde flow is more likely to occur if the pump fluid source is lower in elevation than the entry site of an IV line into the patient""s body, because the inlet pressure is then lower than the outlet pressure due to the head pressure.
The effect that a differential pressure has on the accuracy of the flow rate of a cassette pump depends on whether the pressure at the pump inlet is higher or lower than the pressure at the pump outlet. A higher pump inlet pressure, which is typically due to an increased elevation of the fluid reservoir relative to the pump (i.e., the reservoir head pressure), often causes the flow rate to exceed the desired setting, which the pump is programmed to deliver. Conversely, a higher pump outlet pressure, which can be caused by a partially restricted fluid line connected to the pump outlet or by the entry site into the patient being disposed higher than the pump inlet, can cause the flow rate to decrease below the desired value.
In a balanced pressure environment, cassette pumps tend to act like constant displacement pumps, so that each pumping cycle delivers the same volume of fluid. The delivery rate of the fluid is controlled by varying the number of pumping cycles per unit of time; thus, higher delivery rates require more pumping cycles to be executed during a given time interval than lower delivery rates. The pumping cycle of the prior art cassette pump briefly described above corresponds to a plunger deflecting the elastomeric membrane into the chamber in which the constant volume of fluid is contained, thereby forcing the fluid from the chamber through an outlet valve. The position of the plunger is controlled by a microprocessor. It is possible to change the delivery pressure of the constant volume of fluid to be delivered into the fluid line that is coupled to the patient""s body by adjusting the position of the plunger at the beginning of each pumping cycle. Because the fluid volume delivered during each cycle (and hence the volume of the chamber in which the fluid is contained) is relatively small (generally about 333 xcexcl of fluid is delivered per cycle), a very small change in the initial plunger position will have a significant impact on the pumping chamber pressure.
Clearly, it would be desirable to provide a cassette pump in which a pressure compensated pumping cycle is used to minimize the effect of differential pressures between the inlet and outlet of the pump. A cassette pump achieving this benefit and having accurate flow rates under varying pressure conditions is not disclosed in the prior art. Preferably, such a system would use a multi-component pressure-kinetic model to determine the pressure compensation required due to a differential pressure between the inlet and outlet of the cassette pump. Such a system would preferably use real-time measurements of pressure at both the pump inlet and pump outlet to determine the differential pressure, and then use an empirically determined algorithm to determine the extent to which the position of the plunger should be adjusted to either increase or decrease the delivery pressure. The delivery rate can further be optimized by changing the rate of the pumping cycles as a function of the actual volume delivered during each pump cycle. Preferably such a model would be used to pressure compensate the delivery of medicinal fluids for single or multi-channel cassette pumps. It will thus be apparent that accurately controlling the administration of medicinal fluids under varying pressure conditions using a pressure compensation model would provide significant advantages over the prior art.
In accord with the present invention, a pressure compensated pump is defined for maintaining an accurate delivery of fluid to a patient when a differential pressure exists between an inlet and outlet of the pump. The pump includes a fluid drive unit that is adapted to couple with a fluid line and to force fluid from a source for infusion into the patient through the fluid line. A control unit is coupled to the fluid drive unit to control its operation. A first pressure sensor monitors the inlet pressure to the pump, and a second pressure sensor monitors the outlet pressure of the pump. Both the first and the second pressure sensors are electrically coupled to the control unit. The control unit is programmed to determine a differential pressure between the inlet and the outlet of the pump, and the control unit uses an algorithm stored in a memory to determine a correction factor to be applied to compensate for the differential pressure between the inlet and the outlet, thus ensuring accurate delivery of the fluid to the patient. In addition to correcting for pressure differences across the valves of the pump, the algorithm can include a correction factor that compensates for calibration differences between multiple pressure sensors, as well as a correction factor that compensates for differences between targeted intake fluid volumes and an actual intake fluid volumes, as well as for differences between targeted delivery fluid volumes and actual delivery fluid volumes.
Preferably, the control unit includes a microprocessor responsive to program steps stored in a memory included in the control unit. The pump includes a user interface coupled to the control unit to enable an operator to enter at least one parameter for controlling the delivery of the fluid to the patient, corresponding to either a rate of fluid flow, a volume of fluid flow, a time of fluid flow, and/or a duration of fluid flow.
Also preferably, the correction factor changes a delivery pressure of the fluid, and/or a duration of time between successive cycles of the pump. The algorithm used to determine the correction factor is empirically determined. In a preferred embodiment, the fluid drive unit includes an elastomeric membrane overlying a chamber in the pump. The chamber is in fluid communication with the source and the patient. A driven member that is coupled to a motor exerts a force on the elastomeric membrane, displacing it into the chamber, thereby causing fluid to be expelled from the chamber into the patient. The correction factor determined by the algorithm is expressed as a position of the driven member relative to the elastomeric membrane. In this embodiment, the corrected position of the driven member relative to the elastomeric membrane that is determined by the algorithm corresponds to a corrected position for the driven member at the start of a pump cycle, i.e., before the driven member exerts the force on the elastomeric membrane that causes the fluid to be expelled from the chamber into the patient.
When the control unit determines that the pressure at the outlet of the pump is greater than the pressure at the inlet, the control unit advances the driven member into the chamber to a position determined by the algorithm, and when the control unit determines that the pressure at the outlet is lower than the pressure at the inlet, the control unit retracts the driven member away from the chamber to a position determined by the algorithm. In either case, the driven member is always in contact with the elastomeric membrane during any segment of a pump cycle.
The algorithm employs a first lookup table in which a first value is indicated as a function of a pressure measured by the sensor monitoring the inlet pressure, and a second lookup table in which a second value is indicated as a function of a pressure measured by the sensor monitoring the outlet pressure. The correction factor is determined by combining the first value and the second value obtained from the first and second lookup tables. The lookup tables are preferably empirically determined. The algorithm preferably uses a pressure measured by the sensor monitoring the outlet pressure after the driven member has exerted a force on the elastomeric membrane and the fluid has been displaced and forced into the fluid line toward the patient, in determining the correction factor for the next pump cycle.
After the driven member has exerted a force on the elastomeric membrane and the fluid is forced from the chamber, the control unit uses the algorithm to determine the actual fluid volume delivered to the patient, and then calculates a correction factor that determines how the timing of the next pump cycle is to be modified to maintain a desired delivery rate of the fluid to the patient. The pump preferably includes an inlet valve and an outlet valve.
The correction factor that corresponds to a difference between a targeted intake fluid volume, and an actual intake fluid volume is determined by sampling a first pressure proximate the inlet port after the chamber has been filled with the targeted intake volume by moving the driven member to a first position, and then moving the driven member to a second position, such that the volume of the chamber is decreased. The inlet pressure sensor determines a second pressure proximate the inlet port that exceeds the first pressure proximate the inlet port by a predetermined amount. The algorithm determines the actual intake fluid volume as a function of the first pressure proximate the inlet port, the second pressure proximate the inlet port, the first position of the driven member, and the second position of the driven member; and determines a difference between the targeted intake fluid volume and the actual intake fluid volume. Preferably, the predetermined amount is about 1 psi. The difference between the targeted intake fluid volume and the actual intake fluid volume is used to increase the accuracy of the fluid infusion by adding the difference between the targeted intake fluid volume and the actual intake fluid volume to a targeted intake fluid volume of a subsequent pump cycle. Preferably, the functional relationships between the intake fluid volume, the proximate pressure, and the position of the driven member are empirically determined.
The algorithm can compensate for calibration differences between an inlet pressure sensor and an outlet pressure sensor. The steps employed to accomplish this function include opening the inlet valve while the outlet valve is closed, thus filling the pumping chamber with fluid, and closing the inlet valve when the chamber is filled with a desired volume of fluid. The next step determines a pressure proximate the inlet port and a pressure proximate the outlet port using the inlet and outlet pressure sensors. A position of the elastomeric membrane is adjusted such that a pressure of the fluid within the chamber is equivalent to the pressure proximate the outlet port; and the outlet valve is then opened. Next, the outlet pressure sensor is used to determine if a pressure spike accompanies the opening of the outlet valve (the pressure spike being indicative of a calibration difference between the inlet pressure sensor and the outlet pressure sensor). The pressure spike is used by the algorithm to compensate for the calibration difference in the next pump cycle.
In an alternate embodiment, the pump includes only a pressure sensor in fluid communication with an outlet side of the pump, and a first pump cycle is uncompensated. Two outlet pressure readings are taken during each cyclexe2x80x94one at a beginning of the pump cycle when the chamber is full of fluid, and one just as the fluid is finishing being expelled from the chamber. In the next pump cycle, the position of the driven member is adjusted relative to the chamber to compensate for any differential pressure between the two readings taken in the previous pump cycle.
Another aspect of the present invention is directed to a method that includes steps generally consistent with the functions implemented by the components of the apparatus described above. A further aspect of the present invention is directed to an algorithm that includes steps also generally consistent with the description set forth above.